Experience

Mapp Biopharmaceutical Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, Head of Quality Assurance

  • Jun 2022 - Present

• Director - Quality Assurance

  • Nov 2015 - Jun 2022



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Quality Assurance Consultant

  • May 2010 - Oct 2015

  Oversight of all quality activities including batch disposition of API batches manufactured at External Manufacturing organizations. Ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Review and approve documents including procedures, process flow documents, master production records, change control proposals, and deviations.

• Senior Sourcing Associate

  • Jan 2007 - Apr 2010

  Enable the supply of materials and access to services for internal customers in Development and Manufacturing. Utilize the Lilly Strategic Sourcing Process to provide the greatest value within the allowed timeframe. Support Pharmaceutical Product Development and the large molecule pipeline with working knowledge of manufacturing operations and quality system requirements.

• Raw Materials Coordinator

  • Jun 2003 - Dec 2006

  Coordinating the qualification of materials for the use in GMP processes and for the manufacture of clinical trial material. Development of raw material specifications in conjunction with Quality Assurance. Vendor evaluation and approval.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Research Associate

  • Sep 2000 - Jun 2002

  Clone screening and process optimization of mammalian cell lines used for the production of biotherapeutics. Optimization performed with both small scale and large scale bioreactors. Clone screening and process optimization of mammalian cell lines used for the production of biotherapeutics. Optimization performed with both small scale and large scale bioreactors.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate

  • Sep 1998 - Sep 2000

  Generation and characterization of clonal, serum-free, and suspension adapted mammalian cell lines to be used as platforms for protein expression. Cell line generation and characterization in support of API processes. Evaluation of alternative expression systems for recombinant protein production. Generation and characterization of clonal, serum-free, and suspension adapted mammalian cell lines to be used as platforms for protein expression. Cell line generation and characterization in support of API processes. Evaluation of alternative expression systems for recombinant protein production.



SmithKline Beecham

• King of Prussia, PA

• Scientist

  • Jun 1994 - Sep 1998

  Mammalian and insect cell line generation and characterization. Mammalian and insect cell line generation and characterization.



Fox Chase Cancer Center

• Greater Philadelphia Area

• Scientific Technician

  • Jul 1992 - Jun 1994

  Technical support services in the areas of transgenic and gene knockout technologies. Technical support services in the areas of transgenic and gene knockout technologies.



Children's Hospital of Philadelphia

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Technician

  • May 1991 - Jun 1992

  Technical support services towards the characterization of the location and function of various genes located on chromosome 22. Technical support services towards the characterization of the location and function of various genes located on chromosome 22.